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Identification of Novel Biomarkers to Aid in the Detection of Occult Cancer in Patients With Venous Thromboembolism

Identification of Novel Biomarkers to Aid in the Detection of Occult Cancer in Patients With Venous Thromboembolism

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03781531
Enrollment
1000
Registered
2018-12-20
Start date
2017-03-01
Completion date
2028-12-31
Last updated
2018-12-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer, Venous Thromboembolism

Keywords

Occult cancer, Venous thromboembolism, Biomarkers, Early diagnosis, Neutrophil extracellular traps

Brief summary

Venous thromboembolism is a common and serious complication in cancer, and is associated with a substantially increased morbidity and mortality. Furthermore, VTE may be the earliest sign of cancer. Recent studies, however, fail to show a clinical benefit of extended cancer screening in this patient population. Better risk prediction models are therefore warranted to identify VTE patients who would benefit from a rapid and extensive cancer screening. Inflammation and hypercoagulability are considered hallmarks of cancer, and emerging light is being shed on the potential of various markers of inflammation and coagulation in cancer diagnostics and prognostics. Among the inflammatory and thrombotic processes linked to cancer is the neutrophil release of web-like nuclear chromatin (DNA and histones), referred to as neutrophil extracellular traps (NETs). Driven by the tumor environment, NETs have recently been shown to play a central role in tumor progression, metastasis, and tumor-associated thrombosis. The investigators hypothesize that an enhanced inflammatory state may be predictive of an underlying cancer in patients presenting with VTE. The present study is an ongoing prospective study with the primary aim to investigate the diagnostic potential of markers of inflammation, including markers of NETs, in detecting occult cancer in patients presenting with VTE. Secondary aims are to include other biomarkers of cancer, and to assess whether any or a combination of these biomarkers may be prognostic of occult cancer, recurrent thrombotic events, mortality, or cancer disease progression in VTE patients with an underlying malignancy.

Interventions

None listed

Sponsors

Karolinska Institutet
CollaboratorOTHER
Danderyd Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Venous thromboembolism (thrombosis in the deep venous system of upper or lower extremities or iliac veins and/or pulmonary embolism) as detected by ultrasonography, phlebography, computer tomography, or angiography; * \> 18 years or older; * Written informed consent

Exclusion criteria

* \> 2 days after VTE diagnosis; * No blood withdrawal at baseline

Design outcomes

Primary

MeasureTime frameDescription
CancerWithin 2 years from study inclusionPatients diagnosed with VTE will be referred for a limited cancer screening according to current guidelines. Cancer diagnosis - if not present at inclusion - will be obtained during a two-year follow-up from hospital records and/or the Swedish cancer registry

Secondary

MeasureTime frameDescription
Recurrent thrombotic eventWithin 2 years from study inclusionRecurrent thrombotic event (arterial or venous thrombosis) will be obtained during a two-year follow-up from hospital records and/or the Swedish national patient registry
All-cause mortalityWithin 2 years from study inclusionAll-cause mortality will be obtained during a two-year follow-up from hospital records and/or the Swedish death registry
Cancer progression among enrolled patients with a cancer diagnosis at study inclusionWithin 2 years from study inclusionPatients with cancer progression will be identified during a two-year follow-up from hospital records and/or the Swedish cancer registry

Countries

Sweden

Contacts

Primary ContactCharlotte Thålin, M.D., Ph.D.
charlotte.thalin@sll.se+46709565120
Backup ContactHåkan Wallén, M.D., Prof.
hakan.wallen@ki.se+46707374935

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026